Mild Cognitive Impairment Clinical Trial
Official title:
Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment
NCT number | NCT03545152 |
Other study ID # | 103-7443B |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2015 |
Est. completion date | July 31, 2018 |
Verified date | June 2019 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project is proposed to be a three-year project. The purposes of this project are to develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.
Status | Completed |
Enrollment | 192 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - had a subjective memory complaint - MMSE score<16, 21 or 24, based on their years of education (illiterate, 6 or >9 years, respectively, Yeh et al., 2000), but needed >13 or objective memory impairment: AQ>5 or at least one item of IADL dependence - able to carry out activities in daily life Exclusion Criteria: - using walking devices - depression or dementia diagnosis |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tzu-Ting Huang |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mini-Mental State Examination | The participants' cognitive function was assessed by the Mini-Mental State Examination (cut point base for participants' levels of education). | 8min | |
Primary | The Alzheimer's Questionnaire | Malek-Ahmadi et al., (2012) a 21-item, informant-based dementia assessment designed for ease of use in a primary care setting. | 2min | |
Primary | Taiwan version of Prospectiv and Retrospective Memory Questionaire (PRMQ) | There are 11 items and include general memory and prospective memory sections for analysis the type and frequency of memory problem in elders' daily live. Items are posed in likert scale ranges from 1 (never) to 5 (always). The total score may range from 11-55. A higher score indicates a higher level of memory impaired. | 5min | |
Secondary | Mobility | The Tinetti Performance-Oriented Mobility Assessment (POMA) is a balance tool that was originally developed for use in the institutionalized, older adult population and contains both a balance and a gait component (Tinetti, 1986). The test comprises 16 items (9 balance-related items and 7 gait-related items), with the highest achievable score being 28 points | 10min | |
Secondary | Depressive symptoms | A short-form Geriatric Depression Scale (GDS) that consisted of 15 questions was the primary outcome measure (Sheikh and Yesavage, 1986). Scores of 0-4 are considered normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression. The Chinese version of the GDS-15 demonstrates high reliability (Liao et al., 2005); in this study, the Cronbach's a is .91. | 3min | |
Secondary | Quality of life | The SF-36 questionnaire was used to measure quality of life. This 36-item questionnaire assesses health-related functions for eight distinct domains, which can be divided into physical component and mental component scales. Subsequent to summing the Likert-scaled items in the SF-36 survey, scores in each scale are standardized so that they each range from 0 to 100. | 8min |
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